baclofen

Generic: baclofen

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-473
Product ID 62135-473_24246dff-9253-1075-e063-6394a90a75c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077241
Listing Expiration 2026-12-31
Marketing Start 2007-07-01

Pharmacologic Class

Established (EPC)
gamma-aminobutyric acid-ergic agonist [epc]
Mechanism of Action
gaba a agonists [moa] gaba b agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135473
Hyphenated Format 62135-473

Supplemental Identifiers

RxCUI
197391 197392 430902
UPC
0362135474904 0362135472900 0362135474058 0362135473051 0362135473907
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name baclofen (source: ndc)
Generic Name baclofen (source: ndc)
Application Number ANDA077241 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (62135-473-05)
  • 90 TABLET in 1 BOTTLE (62135-473-90)
source: ndc

Packages (2)

62135-473-05 500 TABLET in 1 BOTTLE (62135-473-05) 62135-473-90 90 TABLET in 1 BOTTLE (62135-473-90)

Ingredients (1)

baclofen (10 mg/1)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24246dff-9253-1075-e063-6394a90a75c0", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0362135474904", "0362135472900", "0362135474058", "0362135473051", "0362135473907"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902"], "spl_set_id": ["2a75db96-590a-43cf-aefb-3bbcb287dbf0"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (62135-473-05)", "package_ndc": "62135-473-05", "marketing_start_date": "20230303"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-473-90)", "package_ndc": "62135-473-90", "marketing_start_date": "20230303"}], "brand_name": "Baclofen", "product_id": "62135-473_24246dff-9253-1075-e063-6394a90a75c0", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "62135-473", "generic_name": "Baclofen", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA077241", "marketing_category": "ANDA", "marketing_start_date": "20070701", "listing_expiration_date": "20261231"}